Healthy
Conditions
Brief summary
Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers.
Detailed description
The objective is to evaluate the effectiveness of the CapScan intestinal collection device in characterizing the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.
Interventions
DEVICECapScan intestinal sampling device
CapScan is an intestinal collection device used to characterize the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.
Sponsors
National Cancer Institute (NCI)
Envivo Bio Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit. Physical Status Classification System 1 or 2. For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit and agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 14 days after the final dose of sulfasalazine. Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form
Exclusion criteria
* • Known or suspected gastrointestinal obstructions, strictures or fistula * Known or suspected moderate to severe dysmotility, by the judgement of the principal investigator * Gastroparesis * A swallowing disorder * Known intolerance, reaction or hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates * Urinary obstruction * Porphyria * Glucose-6-phosphate dehydrogenase deficiency * Known or suspected infection with severe acute respiratory syndrome, HIV, hepatitis B virus or hepatitis C virus * Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding. * Use of concomitant medications, such as aspirin, antibiotics, laxatives and proton pump inhibitors that may interfere with the study in the judgement of the investigator. * Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the principal investigator, to interfere with the conduct of the study. * A clinical condition that, in the judgment of the principal investigator, could potentially pose a health risk to the subject while involved in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional Collection of Metabolites and Gut Microbiota | 2 days | Regional measurement of sulfasalazine in the intestinal lumen, the metabolic breakdown products of sulfasalazine and the gut microbiota in the digestive tracts of healthy volunteers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Open label experimental arm
CapScan intestinal sampling device: CapScan is an intestinal collection device used to characterize the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Regional Collection of Metabolites and Gut Microbiota
Regional measurement of sulfasalazine in the intestinal lumen, the metabolic breakdown products of sulfasalazine and the gut microbiota in the digestive tracts of healthy volunteers.
Time frame: 2 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | Regional Collection of Metabolites and Gut Microbiota | 10 participants with sulfasalazine detected |